MOMENTUM: Combination Product Shows Promise in Migraine

June 02, 2020

A new combination product comprising the triptan rizatriptan and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam has shown promising results in the treatment of migraine.

In the phase 3 MOMENTUM study, the combination product, known as AXS-07 (Axsome Therapeutics), resulted in rapid and sustained pain relief compared with placebo or either rizatriptan or meloxicam alone.

The research was presented on AAN.com as part of the 2020 American Academy of Neurology Science Highlights.

The combination product uses a proprietary formulation (MoSEIC) of meloxicam meant to increase the solubility and speed of absorption of the NSAID.

"The MOMENTUM study selected people with migraine with unmet acute treatment needs, identified using the Migraine Treatment Optimization Questionnaire," co-investigator, Richard Lipton, MD, Albert Einstein College of Medicine, New York City, told Medscape Medical News.

"The study shows that the combination of rizatriptan with MoSEIC meloxicam effectively relieved migraine pain and associated symptoms," Lipton said. "The FDA requires that combination drugs provide greater treatment effects than its components. The MOMENTUM study showed that the combination (AXS-07) was more effective than rizatriptan alone or meloxicam alone."

The MOMENTUM study included 1594 patients with a history of inadequate response to prior acute migraine treatments who were randomized (2:2:2:1) to receive a single dose of AXS-07, rizatriptan, MoSEIC meloxicam, or placebo to treat a migraine of moderate-to-severe pain intensity.

The co-primary endpoints were headache pain freedom and absence of most bothersome symptoms 2 hours post-dosing compared with placebo. Superiority over rizatriptan and MoSEIC meloxicam was assessed based on sustained pain freedom 2 to 24 hours post-dosing.

Results showed that AXS-07 achieved the co-primary endpoints with statistically significant improvements vs placebo on pain freedom at 2 hours (19.9% vs 6.7%; P < .001).

Freedom from most bothersome symptoms at 2 hours occurred in 37% of patients taking the combination product vs 24% given placebo (P = .002).

Rescue medication was used by 23% of patients in the AXS-07 groups vs 35% in those who received either agent individually and 44% of those on placebo.

The percentage of patients achieving pain relief was numerically greater with AXS-07 than with rizatriptan alone at every time point measured.

"The multi-mechanistic approach of AXS-07 may represent a superior treatment choice for patients especially those with more difficult-to-treat migraine," the authors conclude.

Commenting on the study for Medscape Medical News, Stephen Silberstein, MD, director of the Headache Center at Jefferson Health in Philadelphia, said: "These results don't look spectacular, but they have shown better efficacy versus placebo and the individual components of the combination in a difficult to treat population.

"This is not the first time we've seen combination treatment — sumatriptan has been combined with a non-steroidal agent so the principle is there, and the new formulation of meloxicam to improve absorption seems like a good idea."

But Silberstein said he had questions about the cost of the product in relation to the individual components. "What will this branded agent cost, and will insurance companies reimburse this new combination product rather than the use of generic versions of both rizatriptan with meloxicam?" he wondered.

Also commenting for Medscape was A. Laine Green, MD, assistant professor, Geisel School of Medicine at Dartmouth, New Hampshire.

"Those who care for headache patients have long known that the combination of a triptan and an NSAID is often superior to either agent alone," Green said.

"There can sometimes be challenges in having patients take both agents at the same time; there is data to suggest that even though patients leave a physician's office with prescriptions for two medications (a triptan and an NSAID), they often do not fill both prescriptions," he noted. "Thus a combination medication would offer superior compliance and thus superior acute treatment."

"Overall, I see this as a helpful additional tool that we as headache physicians will have access to in order to help improve the lives of those with migraine," Green added.

The MOMENTUM study was funded by Axsome Therapeutics. Several of the co-authors are employees of the company.

American Academy of Neurology (AAN) 2020 Annual Meeting: Abstract 46996. Published online May 18, 2020.

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